Regulatory and Compliance Analyst is needed to perform the following duties:
Assure overall regulatory compliance promoting continuous improvement in our internal
audit
process and risk assessment.
Ensure Pharmacy is compliant with all regulatory, legal and statutory requirements set
forth by state and federal governments.
Develop compliance and participation in audits related to virtual, on-site and paper.
Create reports to assist in the analysis of compliance and safety issues on inspections,
tracers, accounts, regulatory measures, and other core measures.
Coordinating and leading the regulatory responsibility efforts.
Monitor, analyze, interpret, and communicate regulatory changes related to pharmacy and
durable medical equipment.
Making sure biannual licensure renewals and required continuous educations programs
specific to retail pharmacy practice.
Prepare SEC regulatory filings and ensure timely filings (including Form ADV, 13F, 13G,
13H).
Perform internal audits and identify opportunities for improvement.
Timely review of Unbilled and under-payed prescription claims from Centre of Medicaid
and Medicare claims (CMS) and third-party payers.
Working along with Elevate Provider Network regarding the medication reconciliation and
identifying potential MTM opportunities by using MTM outcomes.
Support and improve the efficiency of health plan policy regulatory and strategic plan
of the
pharmacy.
Create and implement compliance tracking, trending, and reporting tools.
Serve as primary contact and representative for all interactions with state and federal
regulatory agencies. Represent the company in audits and inspections.
Working collaboratively with other pharmacy departments and manage to coordinate, plan and
implement compliance improvement projects.
Evaluating the pharmacy policies and organize the reports related to inventory and
compliance following the state and federal rules.
Help the pharmacist keep continuous process update with new compliance
initiatives.
Assist pharmacist in reviewing Center of Medicare & Medicaid service (CMS) prescription data
claims as well as from third party insurance providers.
Assist the pharmacist to reduce potential of regulatory and compliance dispensing errors.
Assist pharmacist in business operations including inventory control, medication adherence,
drug-utilization review (DUR), Comprehensive medication review (CMR), and price
reconciliation.
Assist Pharmacist in developing new methodologies for effective prescription data entry,
central claims for immediate retrieval of records.
Follow CDC Board (Centre of Disease Control) guidelines and news to update any changes in
Immunization methods of practice.
Assist Pharmacist in business operations including inventory control, medication adherence,
drug-utilization review (DUR), Comprehensive medication review (CMR), and price
reconciliation.
Ensure Pharmacy is compliant with all regulatory, legal and statutory requirements set forth
by state and federal governments.
Responsible for regulatory and compliance analyst leading to Medicare and Medicaid laws,
State, Federal laws, DEA rules and Compliance.
Respond to the complaints from the DEA, Insurance audits, HCS, state inspection and related
organizations.
Compliance with applicable state and federal laws, rules and regulations, including but not
limited to Fraud, waste and Abuse (FWA), Centers for Medicare & Medicaid Services (CMS),
Drug Enforcement Agency (DEA), Food and Drug Administration (FDA), Health Insurance
Portability and Accountability Act (HIPAA).
Provide the required State, Federal, Medicaid and Medicare laws compliance support and
assist in the DEA regulations compliance including bringing together the documentation of
expired Controlled substance and the inventory management of control substance consistent
with the strategic plan of the pharmacy.
Submit the control substances submission daily and resolve any issues relate to HCS or PDMP
software.
Maintain Up to date Standard Operating Procedures (SOP) for handling of prescriptions,
filling prescriptions, storage of medications, Refrigerator logs, Daily logs, controlled
substance storage.
Responsible for the development and implementation of maintaining compliance standards
with a focus on rapid development, flexibility, financial integrity, bottom line results,
coordinating logistic, regulatory affairs and implementation strategy.
Execute the strategic and compliance plans for the pharmacy, with particular emphasis on
achieving overall profitability with sales and future expansion.
Distribution and maintenance of acknowledgements, certifications, quarterly and annual
reports, and other documents relating to Code of Ethics reporting and compliance manual.
Assist in data entry and maintenance of information in internal software systems.
Tracking data and creating reports to assist in the analysis of compliance and safety issues
including but not limited to ongoing regulatory monthly inspections, tracers, adverse event
reporting, core measures and other accountability measures.
Generated a report file to securely maintain Prescription Drug Monitoring program (TX PMP)
in order to screen potential drug abuse/illegal activity along with automated submission to
TX board of Pharmacy & DEA.
Retrospective data analysis of prescribing patterns of primary care providers.
Develop and update marketing and advertising policies, programs, and
procedures.
Offer customer service support to both external and internal clients by addressing
inquiries.
Provide compliance advice and guidance on marketing and advertising materials to internal
and external business partners.
Assist in the review of new products and marketing, advertising, and communications
materials to ensure compliance with regulatory requirements under SEC rules.
Establish and maintain effective working relationships with internal and external business
partners.
Assist in the internal audit of our overrides, billing over-dues, coordinating the
diagnostic codes entered in the system regarding use of prescription and non-prescription
drugs.
Timely review of Unbilled and under-payed prescription claims from Centre of Medicaid and
Medicare claims (CMS) and
third party payers.
Working along with Elevate Provider Network regarding the medication reconciliation and
identifying potential MTM opportunities by using MTM outcomes.
Internal auditing of the overrides and the DUR codes used in billing in Prime Rx.
Maintaining the use of proper HCPCS codes and ICD-10 diagnosis codes used in billing the
EMEDNY and EPACES.
Develop operating procedures ensuring corrective and preventive action.
Develop quality assurance techniques to ensure safe and effective inventory control system.
Prevent Fraud, Waste and Abuse (FWA) by literature research on dosing codes along with
diagnosis codes to substantiate the claims.
To make protocols for Dispense As Written (DAW) codes in accordance with state legislature.
Support the operational areas in the implementation of policies, procedures, and other
changes as required.
Providing guidance to associates on the Code of Ethics and other Conflicts of Interest
policies and outside activities.
Develop compliance- related staff education programs and material upon frequent changes made
to the regulatory bodies.
Work with supervising pharmacist to investigate suspected employee misconduct and determine
appropriate discipline for employees found to have committed compliance violations.
Assist with new hire and annual compliance training.
Reviewing, analyzing, and resolving employees’ personal investment transactions and outside
activities to ensure compliance with regulatory restrictions and internal policies,
escalating issues or complex situations as necessary.
Involve in the procedures of review of third-party audit, monitoring drug recall and
product recall.
Making sure any and all overpayments will be refunded to the appropriate third-Party plan,
Medicaid or CMS program within 60 days as per Affordable Care Act 2010.
Monitor Food and Drug Administration (FDA) periodically for voluntary medication recall, the
most effective way to protect public from defective or detrimental products.
Participate in reviewing patient complaints for medication safety and patient awareness
for Health.
Manage Prime RX healthcare program and conduct the Medication Therapy Management services by
providing a link between the patient health assessment and pharmacy.
Coordinate timely approach to medication conjunction with pharmacy patients and provide the
safety measures. Working under pressure ensuring accurate filing and documentation of every
project and its analysis within rules.
Bachelor's Degree is required in Pharmacy or Drug Regulatory Affairs or Pharmaceutical Science
or Pharmaceutics.